Efficacy and Safety Study of Combination Therapy With Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier:
NCT00733616
First received: August 12, 2008
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

The purpose of the study is to determine efficacy and safety of combination therapy with adjusted-dose docetaxel-oxaliplatin-capecitabine in patients with advanced gastric adenocarcinoma and intermediate general status.(defined as ECOG 2 or weight loss 10-25% or older that 70 years and no comorbidities nor functional dependency nor geriatric syndrome)


Condition Intervention Phase
Gastric Cancer
Drug: DOX: Docetaxel, oxaliplatin, Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Adjusted-dose Docetaxel-oxaliplatin-capecitabine in Patients With Advanced Gastric Adenocarcinoma and Intermediate General Status.

Resource links provided by NLM:


Further study details as provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):

Primary Outcome Measures:
  • objective response rate [ Time Frame: 2008-2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events [ Time Frame: 2008-2011 ] [ Designated as safety issue: Yes ]
  • Progression free survival (PFS), time to treatment failure (TTF), overall survival and dose intensity [ Time Frame: 2008-2011 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: DOX: Docetaxel, oxaliplatin, Capecitabine
  • Docetaxel 40 mg/m2, iv infusion 60 minutes, day 1
  • Oxaliplatin 80 mg/m2, iv infusion 120 minutes, day 1
  • Capecitabine 625 mg/m2, bid, oral, continuous

    6 cycles, every 3 weeks

Capecitabine will be given same dose (625mg/m2/bid) continuous in case no toxicity (no dose adjustment)


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. informed consent signed
  2. Histological or cytological adenocarcinoma confirmation carcinoma on the esophago-gastric union or stomach (type I, II and III Siervent) metastatic or relapsed
  3. measurable disease (following RECIST criteria)
  4. older or equal 70 years old
  5. Intermediate general status defined as at least one of the following characteristics: performance status (ECOG) = 2, weight loss ponderada between 10 and 25% in the last 3 months
  6. life expectancy superior to 12 weeks
  7. adequate hematological function: Neutrophils ≥1.50x109, platelets ≥100x109, Hemoglobin ≥10 g/dl
  8. adequate liver function: Liver function (total bilirubine < 2 NV; GOT y GPT <3 NV (< 5 NV in case of liver metastasis; Alkaline phosphatase <3 NV ))
  9. Adequate renal function: renal function (Creatinine clearance > 50mL/min), based on Cockroff - Gault. In case Creatinine clearance is < 50 ml/min, a test in urine will be done in 24 hours and if the value is > 50 ml/min, the patient could be eligible for the study
  10. Potential fertile women negative pregnancy test in serum or urine, 10 days prior the first study dose given
  11. Use an adequate contraceptive method (postmenopausal women should be amenorrheic at least 12 months previous the study to be considered as not potentially fertile (VN:upper limit on normal laboratory values)

Exclusion Criteria:

  1. non measurable lesion as only disease evidence
  2. previous chemotherapy treatment for advance disease. It wont´t be consider as exclusion criteria if chemo or radiotherapy has been given for localized disease and finished more than 1 year ago. In caso os only measurable disease in the radiated area, progressive disease has to be documented previous to the inclusion
  3. functional dependency
  4. hypersensitivity to Docetaxel, oxaliplatin or capecitabine
  5. previous serious adverse events or unexpected to fluoropirimidin treatment and /or patients with proved deficit in dehidropirimidin deshidrogenase (DPD)
  6. patients classified as "weak or fragile"

    1. dependency on one or more of the daily activities following the daily activity scale from Katz
    2. three or more comorbitities of the following: congestive cardiac insufficiency, cardiac valvulopathy, coronaripathia, chronic pulmonary disease (obstructive or restrictive), cerebrovascular disease, diabetes, concomitant neoplasms, collagen vascular disease, chronic hetopathy and incapacitate arthritis
    3. presence of geriatric syndromes: moderate-severe dementia, stress delirium (urinary respiratory infection); moderate-severe depression that interfere in the habitual daily life; frequent falls (3 or more monthly); be disattended; urinary incontinence, without stress, infection, diuretics or prostatic hyperplasia; fecal incontinence without diarrhea or laxative; osteoporotic fracture of long bone or vertebral squash
  7. Cardiac concomitant present:

    1. Symptomatic auriculoventricular arrhythmia history, and /or
    2. Congestive cardiac insufficiency non controlled by drugs, and / or
    3. Myocardial infarct 12 months previous the inclusion, and /or
    4. Symptomatic ischemic cardiopathy
  8. active infectious process ((leukocytes superior to 12 x 109/l or fever upper to 38º, it is required thorax X:ray, hemoculture and urine culture 5 days previous to the inclusion)
  9. severe or bad controlled concomitant disease
  10. neoplastic history (except skin basocellular or in-situ cervical carcinoma properly treated) in the last 5 years
  11. patients with any other medical or surgical important problem that, in the investigator opinion, could not allow to follow the treatment
  12. not able to fulfill the protocol and follow-up
  13. being involve in any investigational trial with any drug within 4 weeks prior the study treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733616

Locations
Spain
Spanish Cooperative Group for Gastrointestinal Tumour Therapy
Madrid, Spain
Sponsors and Collaborators
Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
Sanofi
Hoffmann-La Roche
Investigators
Study Chair: Fernando Rivera, MD; phD Hospital Marques de Valdecilla. Santander. Spain
  More Information

No publications provided

Responsible Party: Spanish Cooperative Group for Digestive Tumour Therapy (TTD)
ClinicalTrials.gov Identifier: NCT00733616     History of Changes
Other Study ID Numbers: TTD-08-02, EudraCT Nº: 2008-001825-32
Study First Received: August 12, 2008
Last Updated: February 19, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Cooperative Group for Digestive Tumour Therapy (TTD):
advanced gastric adenocarcinoma
docetaxel
oxaliplatin
capecitabine
intermediate general status

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014